Friday, January 20, 2023 Daily Archives

Top 10 CGT markers 2022: Approvals aplenty but patient access remains limited

Big Pharma mobilization and a series of approval firsts dominated the seasonal cell and gene therapy review, but failures in patient access post-commercialization took the top spot. In what has become a highlight of Phacilitate’s Advanced Therapies Week, Susan Nichols, chief business officer at ViroCell Biologics, highlighted 10 events from 2022 that drove conversation, investment, and innovation in regenerative medicine. She told delegates in Miami, Florida the past 12 months saw “the highest of the highs” in the cell and…

FDA rejects early approval for Lilly’s Alzheimer’s drug

The US FDA has declined to grant Eli Lilly accelerated approval of monoclonal antibody drug, donanemab. Eli Lilly said the complete response letter (CRL) received from the US Food and Drug Administration (FDA) has been issued due to the limited number of patients with at least one year of drug exposure data provided in the application and stated that no other deficiencies have been identified. The FDA specifically requested that Lilly provide data from a minimum of 100 patients who…